Downstream CQV Engineer
Job in
Holly Springs, Wake County, North Carolina, 27540, USA
Listed on 2026-10-05
Listing for:
Zachary Piper Solutions
Full Time
position Listed on 2026-10-05
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer
Job Description & How to Apply Below
Piper Companies is seeking a Downstream CQV Engineer to support a growing client in the biologics manufacturing industry in Holly Springs, NC. The Downstream CQV Engineer role requires working onsite full-time within a greenfield biologics manufacturing facility. The Downstream CQV Engineer role is ideal for a hands‑on engineering professional with 2-5 years of experience supporting commissioning, qualification, and validation activities, with a strong focus on field execution and IQ/OQ/PQ protocols.
Responsibilities of the Downstream CQV Engineer include:
- Execute commissioning, qualification, and validation activities for downstream process equipment and supporting systems within a biologics manufacturing environment.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol execution, documentation, and troubleshooting.
- Partner closely with engineering, manufacturing, quality, and project teams to ensure systems are transitioned effectively from construction through qualification.
- Support field verification activities, walkdowns, punch list resolution, and turnover package reviews during startup and commissioning phases.
- Ensure all CQV activities are conducted in compliance with GMP requirements, site procedures, and regulatory expectations.
- 2-5 years of experience supporting CQV activities within pharmaceutical, biotech, or life sciences manufacturing environments.
- Hands‑on experience executing IQ, OQ, and PQ protocols for process equipment, utilities, or manufacturing systems.
- Strong field execution background with the ability to work directly on the manufacturing floor during startup and qualification activities.
- Familiarity with GMP regulations, validation lifecycle principles, and commissioning best practices.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- $110,000 - $130,000 annually
- Full Comprehensive Benefits:
Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law. - Opportunity to support a large-scale greenfield biologics manufacturing startup project.
This job opens for applications on 10/2/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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